1. Field of the Invention
The present invention relates to the production of recombinant antibodies (Fab). More particularly, the Fab is produced in large quantities of high purity and fractions. The present invention provides for the process and resultant composition of the bioprocess for the large-scale production of recombinant anti-botulinum toxin antibody.
2. Brief Description of the Prior Art
Genetic engineering has lead to the creation of recombinant antibodies (Fab) which are similar to monoclonal antibodies. These recombinant proteins can be expressed or replicated in large quantities from their host E. Coli cells. However, effective production of these biomolecules requires a bioprocess which can produce them in sufficient quantity and purity at a minimum cost.
Previously, the anti-botulinum toxin antibody has been produced in bench-scale quantities only. This increases the cost and produces a smaller total yield. Previously known processes for purifying the Fab were generally not amenable to scale-up to larger quantities and did not provide an optimal large-scale process. In general, low yield production significantly impacts on the ability to produce anti-botulinum. Moreover, limitations in the previous known process have restricted the quantity and purity of the Fab production.
In view of the foregoing, improvements in the production of Fab have been desired. In addition to the increase in quantity and purity, a one-column process is desired for the process to further enhance production.
The present invention addresses these needs.